Systems, Devices, and Methods for Landmarking a Medical Device

Abstract

Disclosed are medical systems, devices, and methods that support landmarking of a medical device pathway within a patient. A landmarking device that is placed on the patient and coupled with a system module, includes magnetic elements and/or a shape sensing optical fiber to enable determining a position and shape of a landmarking pathway by logic of the system module. A medical device correspondingly includes magnetic elements and/or a shape sensing optical fiber that enable determining an actual pathway of the medical device by logic of the system module during insertion of the medical device. An image of the landmarking pathway combined with an image of the actual pathway are depicted on a display. The logic compares the actual pathway with the landmarking pathway and provides an alert accordingly.

1 . A medical system, comprising:
 an elongate landmarking device configured for placement across an exterior of the patient, the landmarking device, comprising a plurality of landmarking elements extending along a length of the landmarking device; and   a system module comprising a console operably coupled with the landmarking device, the console having a number of processors and memory including a non-transitory computer-readable medium, having logic stored thereon that, when executed by the processors, performs operations, including:
 receiving, by the system module, landmarking signals originating from the plurality of landmarking elements; and 
 defining one or more digital landmarks of the landmarking device based on the received landmarking signals, wherein:
 the plurality of landmarking elements are arranged along the landmarking device to define the one or more digital landmarks, and 
 the digital landmarks are configured to indicate a desired insertion pathway for an elongate medical device. 
 
   
     
     
         2 . The system according to  claim 1 , wherein the operations further include defining a landmarking pathway based on the one or more digital landmarks. 
     
     
         3 . The system according to  claim 2 , wherein the operations further include storing the landmarking pathway in memory. 
     
     
         4 . The system according to  claim 1 , wherein:
 the landmarking elements include landmarking magnetic elements, and   the received landmarking signals include magnetic signals emanating from the landmarking magnetic elements.   
     
     
         5 . The system according to  claim 1 , wherein the landmarking device includes a shapable elongate member. 
     
     
         6 . The system according to  claim 5 , wherein the landmarking magnetic elements are disposed along the shapable elongate member. 
     
     
         7 . The system according to  claim 6 , wherein the landmarking magnetic elements are positionable along the shapable elongate member. 
     
     
         8 . The system according to  claim 5 , wherein:
 the landmarking elements include a landmarking optical fiber extending along the shapable elongate member,   the landmarking optical fiber includes multiple optical fiber cores having a number of optical fiber gratings disposed along the multiple optical fiber cores,   the number of optical fiber gratings define reflected optical signals based on a shape of the shapable elongate member,   the landmarking optical fiber is optically coupled with the console, and   the received landmarking signals include the reflected optical signals propagated proximally along the landmarking optical fiber.   
     
     
         9 . The system according to  claim 1 , further comprising:
 an elongate medical device configured for insertion within a patient, wherein the elongate medical device:
 is operably coupled with the console, and 
 includes a number of device tracking elements disposed along the elongate medical device. 
   
     
     
         10 . The system according to  claim 9 , wherein the operations further include:
 receiving, by the system module, device tracking signals originating from the device tracking elements disposed along the elongate medical device; and   determining an actual pathway of the elongate medical device inserted into the patient, the actual pathway based on the received device tracking signals.   
     
     
         11 . The system according to  claim 10 , wherein:
 the console is coupled with a display, and   the operations further include depicting an image of the landmarking pathway in combination with an image of the actual pathway on the display.   
     
     
         12 . The system according to  claim 10 , wherein the operations further include:
 comparing the landmarking pathway with the actual pathway; and   providing an alert in response to the comparison when the actual pathway deviates from the landmarking pathway beyond a defined deviation limit.   
     
     
         13 . The system according to  claim 9 , wherein:
 the device tracking elements include tracking magnetic elements disposed along the elongate medical device, and   the received device tracking signals include magnetic signals emanating from the tracking magnetic elements.   
     
     
         14 . The system according to  claim 13 , wherein the landmarking device and the elongate medical device are simultaneously coupled with the console. 
     
     
         15 . The system according to  claim 13 , wherein:
 at least one of the landmarking device or the elongate medical device is optically coupled with the console, and   at least the other one of the landmarking device or the elongate medical device is magnetically coupled with the console.   
     
     
         16 . The system according to  claim 13 , wherein the landmarking device and the elongate medical device are simultaneously magnetically coupled with the console. 
     
     
         17 . The system according to  claim 9 , wherein:
 the elongate medical device includes a device optical fiber extending along the elongate medical device,   the device optical fiber includes multiple device optical fiber cores having a number of device optical fiber gratings disposed along the multiple device optical fiber cores,   the number of device optical fiber gratings define reflected device optical signals based on a shape of the elongate medical device,   the device optical fiber is optically coupled with the console, and   the received device tracking signals include the reflected device optical signals propagated proximally along the device optical fiber.   
     
     
         18 . The system according to  claim 17 , wherein the landmarking device and the elongate medical device are simultaneously optically coupled with the console. 
     
     
         19 . The system according to  claim 17 , wherein the landmarking device and the elongate medical device are simultaneously optically and magnetically coupled with the console. 
     
     
         20 . The system according to  claim 1 , wherein the landmarking device includes a catheter. 
     
     
         21 . The system according to  claim 1 , wherein the landmarking device is configured for insertion into a lumen of a vascular catheter. 
     
     
         22 - 40 . (canceled) 
     
     
         41 . A landmarking device for mapping an insertion pathway of a vascular device, comprising:
 a shapable elongate member configured for placement on a patient exterior along a desired internal pathway for the vascular device; and   a number of landmarking elements disposed along the shapable elongate member, each landmarking element including a characteristic detectable by a medical device tracking system.   
     
     
         42 . The device according to  claim 41 , wherein the landmarking elements include landmarking magnetic elements configured to define a magnetic field detectable by a plurality of magnetometers of the medical device tracking system. 
     
     
         43 . The device according to  claim 42 , wherein the landmarking magnetic elements are positionable along the shapable elongate member. 
     
     
         44 . The device according to  claim 41 , wherein:
 the landmarking elements include a landmarking optical fiber extending along the shapable elongate member,   the landmarking optical fiber includes multiple optical fiber cores having a number of optical fiber gratings disposed along the multiple optical fiber cores, and   the number of optical fiber gratings define reflected optical signals based on a shape of the landmarking optical fiber,   the landmarking optical fiber is configured to optically couple with the medical device tracking system such that the reflected optical signals are detectable by the medical device tracking system.   
     
     
         45 . The device according to  claim 41 , wherein the landmarking device includes a catheter. 
     
     
         46 . The device according to  claim 41 , wherein the landmarking device is configured for insertion within a lumen of a vascular catheter.